AzTrials
AzTrials

Cardiovascular DiseaseNCT01259700

High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China

A study testing High-risk patient standardized management package and Community based salt reduction program in people with Cardiovascular Disease, run by The George Institute for Global Health, China at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiovascular Disease
What is being tested?
High-risk patient standardized management package and Community based salt reduction program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesChina
Study dates
Dec 2010to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Physician-diagnosed history of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or
  • Older age (50 years or older for men; 60 years or older for women) and having physician-diagnosed Type I or Type II diabetes
  • Older age (50 years or older for men; 60 years or older for women) and systolic blood pressure 160 mmHg (note that for simplicity, diastolic blood pressure is not included in the criteria)

Who cannot join

  • none

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Changzhi Medical College, China

    Changzhi, Shanxi

  • The First Hospital Of China Medical University

    Shenyang, Liaoning

  • Hebei Province Center for Disease Prevention and Control ,China

    Shijiazhuang, Hebei

  • The Xi'an Jiaotong University School of Public Health

    Xi’an, Shanxi

  • Ningxia Medical University School of Public Health

    Yinchuan, Ningxia

Other trials in China

About this study

Official title: China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials

Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.

Being tested
High-risk patient standardized management package, Community based salt reduction program
Keywords
High blood pressure, Primary care, Cardiovascular disease prevention, Salt reduction
Medical subject headings
Cardiovascular Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-risk patient standardized management packageBehavioural

    Also called high risk management

    A primary-care based high cardiovascular risk management package delivered by village doctors

  • Community based salt reduction programBehavioural

    Also called Salt reduction

    A community-based salt reduction program delivered mainly by community health educators

Study groups in NCT01259700
Study groupRoleWhat they receive
High risk managementExperimentalNot described
Receives: Behavioral: High-risk patient standardized management package
Salt reductionExperimentalNot described
Receives: Behavioral: Community based salt reduction program
high risk management and salt reductionExperimentalNot described
Receives: Behavioral: High-risk patient standardized management package; Behavioral: Community based salt reduction program
Usual careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean systematic blood pressure level

    Measured: October 2010 - December 2012

  2. 24 hour urinary sodium

    Measured: October -December 2012

Secondary outcomes (6)

  1. 24 hour urinary potassium

    Measured: October-December 2012

  2. Urinary sodium:potassium ratio

    Measured: October-December 2012

  3. Receiving regular primary care

    Measured: October 2010 -December 2012

  4. Taking anti-hypertensive medications

    Measured: October 2010 -December 2012

  5. Taking aspirin

    Measured: October 2010 -December 2012

  6. Receiving therapeutic lifestyle recommendations from village doctors

    Measured: Oct 2010 - Dec 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01259700
Sponsor's protocol ID
Pro00025963
Other IDs
HHSN268200900027C
Status last verified
Feb 2016
First submitted
13 Dec 2010
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen S, Yan LL, Feng X, Zhang J, Zhang Y, Zhang R, Zhou B, Wu Y. Population-wide impact of a pragmatic program to identify and manage individuals at high-risk of cardiovascular disease: a cluster randomized trial in 120 villages from Northern China. Front Cardiovasc Med. 2024 May 24;11:1372298. doi: 10.3389/fcvm.2024.1372298. eCollection 2024.

    PubMed 38854653

  • McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

    PubMed 34164803

  • Jardine MJ, Li N, Ninomiya T, Feng X, Zhang J, Shi J, Zhang Y, Zhang R, Zhang J, Hao J, Perkovic V, Heerspink HL, Wu Y, Yan LL, Neal B. Dietary Sodium Reduction Reduces Albuminuria: A Cluster Randomized Trial. J Ren Nutr. 2019 Jul;29(4):276-284. doi: 10.1053/j.jrn.2018.10.009. Epub 2018 Dec 24.

    PubMed 30591358

  • Li N, Yan LL, Niu W, Yao C, Feng X, Zhang J, Shi J, Zhang Y, Zhang R, Hao Z, Chu H, Zhang J, Li X, Pan J, Li Z, Sun J, Zhou B, Zhao Y, Yu Y, Engelgau M, Labarthe D, Ma J, MacMahon S, Elliott P, Wu Y, Neal B. The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial. PLoS One. 2016 Dec 9;11(12):e0166620. doi: 10.1371/journal.pone.0166620. eCollection 2016.

    PubMed 27935977

  • Wang X, Li X, Vaartjes I, Neal B, Bots ML, Hoes AW, Wu Y. Does education level affect the efficacy of a community based salt reduction program? - A post-hoc analysis of the China Rural Health Initiative Sodium Reduction Study (CRHI-SRS). BMC Public Health. 2016 Aug 11;16(1):759. doi: 10.1186/s12889-016-3454-6.

    PubMed 27515930

  • Zhang J, Wu T, Chu H, Feng X, Shi J, Zhang R, Zhang Y, Zhang J, Li N, Yan L, Niu W, Wu Y. Salt intake belief, knowledge, and behavior: a cross-sectional study of older rural Chinese adults. Medicine (Baltimore). 2016 Aug;95(31):e4404. doi: 10.1097/MD.0000000000004404.

    PubMed 27495056

  • Yan LL, Fang W, Delong E, Neal B, Peterson ED, Huang Y, Sun N, Yao C, Li X, MacMahon S, Wu Y. Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial. BMC Public Health. 2014 Apr 11;14:345. doi: 10.1186/1471-2458-14-345.

    PubMed 24721435

Questions about this trial

What is this clinical trial studying?

A study testing High-risk patient standardized management package and Community based salt reduction program in people with Cardiovascular Disease, run by The George Institute for Global Health, China at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean systematic blood pressure level (time frame: October 2010 - December 2012). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01259700, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in